To provide written guidelines regarding the use of surrogate decision-makers in the informed consent process, when adult subjects with impaired consent capacity are enrolled in research.

POLICY

The CHS Institutional Review Board complies with California State Law, Section 24178 of the Health and Safety Code, regarding surrogate consenting. With IRB approval, certain research studies are eligible for use of a surrogate decision-maker.

This policy currently reflects:

The California Health and Safety Code, Sections 24170 to 24179.5 (also known as the Human Subjects in Medical Experimentation Act), specifically sections 24175 and 24178.

45 CFR 46 - Protection of Human Subjects

DEFINITIONSCognitive Impairment: A psychiatric disorder, an organic impairment, or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.

Medically Incapacitated: Helpless or powerless by illness or injury, including conditions such as lack-of-consciousness. A person who is incapacitated as a result of prescribed sedatives, anesthesia, or other medication. Other examples include: persons under the influence of, or dependent on, drugs or alcohol; those suffering from degenerative disease affecting the brain; terminally ill patients; and persons with severely disabling physical handicaps.

Surrogate Decision-Maker: An advocate who represents and speaks for an incompetent patient with regard to the desires for the patient's life. Also known as a health care proxy or agent. The Code of Federal Regulations, Section 45 Part 46, stipulates such individuals as ÒLegally Authorized Representatives.

PROCEDURE

I. General Information

Under current California State Law (Section 24178 of the California Health and Safety Code), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decision-maker with reasonable knowledge of the subject.

The law also stipulates that cognitively-impaired or medically incapacitated individuals can only be enrolled in research by a surrogate decision-maker when:

the research is about the condition causing the lack of capacity/cognitive impairment; or

the research involves serious or life threatening conditions.

Surrogates are prohibited from receiving any financial compensation for providing consent. This does not prohibit the surrogate from being reimbursed for expenses the surrogate may incur related to the surrogate's involvement in the research.

Surrogate consent to participate in research under California Health & Safety Code section 24178 is not permitted for persons on an inpatient psychiatric ward, inpatients of a mental health facility, or persons on psychiatric hold. NOTE: This is more restrictive than the standard under previously existing law whereby an incapacitated adult with a conservator or guardian could be enrolled onto a study being conducted in an inpatient psych unit because conservators and guardians were considered legally-authorized representatives.

In protocols in which a surrogate's consent has been approved by the IRB, assessment of the decision-making capacity of the surrogate should also be implemented when the investigator has reason to believe that the surrogate's decision-making
capacity may be impaired.

II. IRB Approval

Consistent with state law, the IRB uses the following criteria when determining whether to permit the use of surrogate consent for participation in a research study:

Surrogate consent is requested through the application process for new research studies or through the protocol amendment process for an existing protocol.

There must be a detailed protocol-specific plan for the sequence of steps that will be employed by the researcher(s) to acquire and document surrogate consent provided by a legally authorized representative. The researcher must include a description of this plan and provide details of how the decision-making capacity of subjects will be assessed and by whom.

Researchers are encouraged to use a decision-making capacity tool for assessing competency to consent, such as the Mini-Mental State Examination (MMSE) or the 6 Item Cognitive Impairment Test (6-CIT).

When the IRB approves surrogate consent for a protocol, it is with the understanding that, whenever possible, investigators will attempt to obtain informed consent directly from the subjects.

Modification requests to add cognitively impaired or medically incapacitated populations and/or surrogate consent is considered a significant change to the protocol and must be reviewed by the Full Board.

As in all human subjects research, the IRB must carefully consider the risk/benefit ratio of the particular study for the targeted population.

The IRB may consider whether the frequency of a specific protocol's review cycle should be reasonably modified when surrogate consent is implemented.

III. Investigator Guidance

The request for the use of a surrogate decision-maker must be made in writing at the time of IRB submission of the research application using the Surrogate Consent Addendum. The IRB will determine, as part of the approval, if a surrogate decision-maker may be used. Depending upon the study, the use of surrogates may be permitted (as needed):

For some subjects only (those who are unable to consent-for-self, but are otherwise eligible for enrollment due to a serious or life-threatening condition);

For all subjects (the condition resulting in their lack of capacity is an eligibility criteria).

Upon approval by the IRB for use within a specific protocol, the investigator shall assess the situation and apply the use of surrogate consent on a case-by-case basis within that protocol.

The IRB asks that investigators closely evaluate the risks associated with the patient's enrollment and weigh them against the potential benefits to the patient, prior to asking for consent from the patient's surrogate.

A. Determining the Decision-Making Capacity of the Subject

Whenever possible, investigators will attempt to obtain informed consent directly from the subject.

If the investigator determines that the subject lacks decision-making capacity, the investigator shall, consistent with the standard consent process, describe the research to the subject and the investigator's intent to obtain surrogate consent; this communication should be documented in the research file, supplemented with a brief note in the subject's medical record, which references the research file and confirms that the research protocol was described to the subject. However, if the investigator determines that the subject is unresponsive, the investigator shall document that observation in the research file, supplemented with a brief note in the subject's medical record, which again references the research file. Under such circumstances, the required discussion described above regarding intent to seek surrogate consent shall be waived.

Unless information is otherwise provided by those most likely to understand the patient's state of mind (i.e. next-of-kin), it would be assumed that the patient would want to have an opportunity for improvement. However, if the subject expresses resistance or dissent to participation or to the use of surrogate consent by word or gesture, the subject shall be excluded from the research study.

While there are no standardized measures for determining capacity to consent, investigators may assess subjects on their abilities to understand and to express a reasoned choice concerning the:

Nature of the research and the information relevant to his/her participation;

Consequences of participation for the subject's own situation, especially concerning the subject's health condition; and

Consequences of the alternatives to participation.

The capacity to understand all of these concepts may not be necessary in order to be able to consent to participate in some research protocols, albeit greater capacity is required for higher-risk protocols. The same standards should be used for determining the capacity of the surrogate as well, if necessary.

1. In a non-emergency room environment: Surrogate consent may be obtained from any of the following potential surrogates who have reasonable knowledge of the subject, in the following descending order of priority:

The person's agent designated by an advance health care directive.

The conservator or guardian of the person having the authority to make health
care decisions for the person.

The spouse of the person.

The domestic partner of the person as defined in Section 297 of the Family Code.

An adult son or daughter of the person.

A custodial parent of the person.

Any adult brother or sister of the person.

Any adult grandchild of the person.

An available adult relative with the closest degree of kinship to the person.

In non-emergency room research settings, no surrogate consent may be utilized if there is a disagreement whether to consent among the members of the highest available priority class of surrogates, (e.g., where two members of persons in the highest of categories (5) - (7) disagree and there is no person in categories (1) - (4) available.

In non-emergency room research settings only, the investigator is responsible for ensuring that the surrogate:

Has reasonable knowledge of the subject;

Is familiar with the subject's degree of impairment;

Is willing to serve as the substitute decision-maker;

Understands the risks, potential benefits, procedures and available alternatives to research participation;

Makes decisions based on the subject's known preferences, and where the subject's preferences are unknown, makes decisions based upon the surrogate's judgment of what the subject's preferences would be.

2. In an emergency room setting: The order of priority does not apply, nor does the surrogate have to show reasonable knowledge of the subject. Surrogate consent may be obtained from a surrogate decision maker who is any of the following:

The spouse of the person.

The domestic partner of the person as defined in Section 297 of the Family Code.

An adult son or daughter of the person.

A custodial parent of the person.

Any adult brother or sister of the person.

In emergency room research settings, no surrogate consent may be utilized if there is a disagreement whether to consent among any available surrogates.
3. Guidance on the LAR Consent Form Signature Section:

Investigators shall describe to potential surrogates the nature of ongoing decisions during the study regarding the subject's participation, decision to participate in certain procedures, changes to the study, etc., in order to ensure that the surrogate will be willing to undertake these on-going responsibilities.

The surrogate shall complete the Legally Authorized Representative (LAR) consent form signature section for the research study. The LAR consent form signature section verifies the willingness of the person to serve as a surrogate and details the relationship of the surrogate to the subject.

In non-emergency room settings, potential surrogates must be advised that if a higher-ranking surrogate is identified at any time, the investigator will defer to the higher-ranking surrogate's decision regarding the subject's participation in the research.

For non-emergency room environment research only, if the potential surrogate identifies a person of a higher degree of surrogacy, the investigator is responsible to contact such individuals to determine if they want to serve as surrogate.

C. Re-Consenting Subjects

Consenting is an ongoing process. All applicable criteria that would trigger re-consenting a subject in any study shall apply to subjects whose consent has been provided by a surrogate.

A subject who regains the cognitive ability to consent must be re-consented using standard consenting procedures.

In the event a subject has been initially consented by a surrogate, and a surrogate of higher priority subsequently notifies the investigator of that relationship to the subject, the investigator must defer to the higher priority surrogate's decision regarding whether the subject will continue to participate or withdraw from the study.

In the event that the surrogate dies, the subject must be re-consented subsequently upon any event that would otherwise trigger re-consenting the subject.

IV. Section 24178 of the California Health and Safety Code

24178. (a) Except for this section and the requirements set forth in Sections 24172 and 24176, this chapter shall not apply to any person who is conducting a medical experiment as an investigator
within an institution that holds an assurance with the United States Department of Health and Human Services pursuant to Part 46 of Title 45 of the Code of Federal Regulations and who obtains informed
consent in the method and manner required by those regulations.

(b) Subdivisions (c) and (f) shall apply only to medical experiments that relate to the cognitive impairment, lack of capacity, or serious or life threatening diseases and conditions of research participants.

(c) For purposes of obtaining informed consent required for medical experiments in a non-emergency room environment, and pursuant to subdivision (a), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decision-maker with reasonable knowledge of the subject, who shall include any of the following persons, in the following descending order of priority:

The person's agent pursuant to an advance health care
directive.

The conservator or guardian of the person having the authority to make health care decisions for the person.

The spouse of the person.

An individual as defined in Section 297 of the Family Code.

An adult son or daughter of the person.

A custodial parent of the person.

Any adult brother or sister of the person.

Any adult grandchild of the person.

An available adult relative with the closest degree of kinship

to the person.

(d) When there are two or more available persons who, pursuant to subdivision (c), may give surrogate informed consent and who are in the same order of priority, if any of those persons expresses dissent as to the participation of the person in the medical experiment, consent shall not be considered as having been given.

(e) When there are two or more available persons who are in different orders of priority pursuant to subdivision (c), refusal to consent by a person who is a higher priority surrogate shall not be superseded by the consent of a person who is a lower priority surrogate.

(f) For purposes of obtaining informed consent required for medical experiments in an emergency room environment, and pursuant to subdivision (a), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decision-maker who is any of the following persons:

The person's agent pursuant to an advance health care
directive.

The conservator or guardian of the person having the authority
to make health care decisions for the person.

The spouse of the person.

An individual defined in Section 297 of the Family Code.

An adult son or daughter of the person.

A custodial parent of the person.

Any adult brother or sister of the person.

(g) When there are two or more available persons described in subdivision (f), refusal to consent by one person shall not be superceded by any other of those persons.

(h) Research conducted pursuant to this section shall adhere to federal regulations governing informed consent pursuant to Section 46.116 of Title 45 of the Code of Federal Regulations.

(i) Any person who provides surrogate consent pursuant to subdivisions (c) and (f) may not receive financial compensation for providing the consent.

(j) Subdivisions (c) and (f) do not apply to any of the following persons, except as otherwise provided by law:

Persons who lack the capacity to give informed consent and who are involuntarily committed pursuant to Part 1 (commencing with Section 5000) of Division 5 of the Welfare and Institutions Code.

Persons who lack the capacity to give informed consent and who have been voluntarily admitted or have been admitted upon the request of a conservator pursuant to Chapter 1 (commencing with Section 6000) of Part 1 of Division 6 of the Welfare and Institutions Code.